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AUA 2022: A report from the trenches
The annual meeting of the American Urological Association took place recently at the Ernest N. Morial Convention Center in New Orleans.
1. Updates to the AUA’s guidelines for management of localized kidney cancer
The AUA’s recommendations for the treatment of localized kidney cancer have changed dramatically over the past few decades. Gone are the days of simply removing the entire kidney every time a mass is found. Today, a partial nephrectomy is preferred in most situations.
Our understanding that the prevalence of familial kidney cancer is much higher than previously thought has led to a change in the guidelines regarding which patients should receive genetic counseling. For the first time, the guidelines include the use of adjuvant medical treatment, such as pembrolizumab. A 2021 study in the New England Journal of Medicine showed a survival benefit for patients with high-risk disease who receive such therapies, so it›s not surprising that such treatments are now recommended.
The development of new second- and third-generation gadolinium contrast agents that spare the kidneys has dramatically increased the role for MRIs for patients with severe or even end-stage renal disease. As a result, the guidelines were updated to recommend the use of these agents. The role of a renal biopsy, which has always been limited, given the ability of cross-sectional imaging to diagnosis this disease, has further been constrained and should now be performed only when the results would clearly change a clinical decision, such as whether or not the lesion in question is a metastasis.
2. New and better ureteroscope technology
No one likes kidney stones, not the patient who deals with the incredible pain, nor the surgeon who has to remove them, given that these cases often present in the wee hours of the morning. The preferred surgical approach has changed dramatically over the past decade, moving away from extracorporeal shockwave lithotripsy toward flexible ureteroscope-based technology, which has a higher clearance rate and is more widely and more immediately available. Flexible ureteroscopy has been held back by technological barriers, including limited scope deflection and low laser power. The exceptionally high cost of repair and the tendency of the instruments to break haven’t helped, either. Although single-use ureteroscopes have been available for some time, it wasn’t until the recently introduced second-generation scopes became widely available that they have become popular. These new scopes have small external diameters, great optics, and can easily be used. Newer high-powered lasers and the change from holmium:YAG-based lasers to thulium technology is greatly increasing the size of stones that can be safely addressed ureteroscopically. The cost analysis of single-use technology versus reusable scopes tends to be site dependent but can be appealing in certain situations. Also, on the technology forefront, a new robotically assisted ureteroscope is being introduced that offers the chance for improved intrapelvic mobility and better ergonomics for the surgeon.
3. New options for the treatment of clinically localized prostate cancer
Since the guidelines were last updated in 2017, the definitive management of localized prostate cancer has changed dramatically. Although radical prostatectomy and radiotherapy remain the preferred options for men who choose treatment for their disease, the updated guidelines state that active surveillance is now the preferred approach for men with low-risk cancers.
Although the preferred surveillance protocol is still being debated, the consensus is that almost all men with low-risk disease can be safely monitored for some period. The imaging technology available to monitor patients is also radically changing with the rollout of prostate-specific membrane antigen–based PET technology. The increased sensitivity and specificity of this modality opens the door not only for better up-front staging of newly diagnosed patients with prostate cancer but also may allow clinicians to earlier identify and treat men with metastatic disease. The guidelines for the first time address the use of genetic markers to individualize treatment of men with advanced or metastatic prostate cancer. Exactly which treatments these patients need is still being debated, but the ability to use patient-specific genetic mutation information to customize treatment is potentially groundbreaking.
4. New treatment options for patients with high-grade non–muscle-invasive bladder cancer (NMIBC) refractory to bacille Calmette-Guérin (BCG) therapy
Patients with NMIBC who do not respond to BCG therapy are in a tough position. Cystectomy remains the preferred option as a second-line strategy, but the procedure has a complication rate approaching 30%. Further, many patients are not willing to have their bladder removed because of the life-altering changes that go along with having an urostomy or a neobladder. While intravesical treatments such as valrubicin, docetaxel, or gemcitabine have been available for many years, the success rates of those options are limited. The Food and Drug Administration recently approved the use of the immunotherapy-based treatment pembrolizumab. While none of these options is perfect, the fact that we now have at least some alternatives is a huge step in the right direction.
5. It’s all about the patient: Involving patients in designing the health care delivery system
Although it seems like an obvious concept, patients themselves have traditionally not been involved in designing the health care delivery system on which they rely. Research presented at the AUA shows that many health care outcomes improve when patients are actively involved in the process. For example, Angela Smith, MD, of the University of North Carolina at Chapel Hill, presented a study showing that including patients in the identification of possible research topics helps them feel engaged and more likely to participate in studies. Patients who are involved in advisory councils at the local hospital level are more likely to report having received high-quality care. And surveying patients on the goals of national health care policy helps them feel that the outcomes are more equitable.
As a small-town urologist who spends his days in the trenches of urology, I think the next time my group considers participating in new cancer research, I may talk to the local cancer support group first. If Dr. Smith’s data are correct, not only would our patients be better served, but we would also have an easier time filling the trial!
The 2023 AUA conference is going to be held in Chicago next spring. I hope to see you there!
A version of this article first appeared on Medscape.com.
The annual meeting of the American Urological Association took place recently at the Ernest N. Morial Convention Center in New Orleans.
1. Updates to the AUA’s guidelines for management of localized kidney cancer
The AUA’s recommendations for the treatment of localized kidney cancer have changed dramatically over the past few decades. Gone are the days of simply removing the entire kidney every time a mass is found. Today, a partial nephrectomy is preferred in most situations.
Our understanding that the prevalence of familial kidney cancer is much higher than previously thought has led to a change in the guidelines regarding which patients should receive genetic counseling. For the first time, the guidelines include the use of adjuvant medical treatment, such as pembrolizumab. A 2021 study in the New England Journal of Medicine showed a survival benefit for patients with high-risk disease who receive such therapies, so it›s not surprising that such treatments are now recommended.
The development of new second- and third-generation gadolinium contrast agents that spare the kidneys has dramatically increased the role for MRIs for patients with severe or even end-stage renal disease. As a result, the guidelines were updated to recommend the use of these agents. The role of a renal biopsy, which has always been limited, given the ability of cross-sectional imaging to diagnosis this disease, has further been constrained and should now be performed only when the results would clearly change a clinical decision, such as whether or not the lesion in question is a metastasis.
2. New and better ureteroscope technology
No one likes kidney stones, not the patient who deals with the incredible pain, nor the surgeon who has to remove them, given that these cases often present in the wee hours of the morning. The preferred surgical approach has changed dramatically over the past decade, moving away from extracorporeal shockwave lithotripsy toward flexible ureteroscope-based technology, which has a higher clearance rate and is more widely and more immediately available. Flexible ureteroscopy has been held back by technological barriers, including limited scope deflection and low laser power. The exceptionally high cost of repair and the tendency of the instruments to break haven’t helped, either. Although single-use ureteroscopes have been available for some time, it wasn’t until the recently introduced second-generation scopes became widely available that they have become popular. These new scopes have small external diameters, great optics, and can easily be used. Newer high-powered lasers and the change from holmium:YAG-based lasers to thulium technology is greatly increasing the size of stones that can be safely addressed ureteroscopically. The cost analysis of single-use technology versus reusable scopes tends to be site dependent but can be appealing in certain situations. Also, on the technology forefront, a new robotically assisted ureteroscope is being introduced that offers the chance for improved intrapelvic mobility and better ergonomics for the surgeon.
3. New options for the treatment of clinically localized prostate cancer
Since the guidelines were last updated in 2017, the definitive management of localized prostate cancer has changed dramatically. Although radical prostatectomy and radiotherapy remain the preferred options for men who choose treatment for their disease, the updated guidelines state that active surveillance is now the preferred approach for men with low-risk cancers.
Although the preferred surveillance protocol is still being debated, the consensus is that almost all men with low-risk disease can be safely monitored for some period. The imaging technology available to monitor patients is also radically changing with the rollout of prostate-specific membrane antigen–based PET technology. The increased sensitivity and specificity of this modality opens the door not only for better up-front staging of newly diagnosed patients with prostate cancer but also may allow clinicians to earlier identify and treat men with metastatic disease. The guidelines for the first time address the use of genetic markers to individualize treatment of men with advanced or metastatic prostate cancer. Exactly which treatments these patients need is still being debated, but the ability to use patient-specific genetic mutation information to customize treatment is potentially groundbreaking.
4. New treatment options for patients with high-grade non–muscle-invasive bladder cancer (NMIBC) refractory to bacille Calmette-Guérin (BCG) therapy
Patients with NMIBC who do not respond to BCG therapy are in a tough position. Cystectomy remains the preferred option as a second-line strategy, but the procedure has a complication rate approaching 30%. Further, many patients are not willing to have their bladder removed because of the life-altering changes that go along with having an urostomy or a neobladder. While intravesical treatments such as valrubicin, docetaxel, or gemcitabine have been available for many years, the success rates of those options are limited. The Food and Drug Administration recently approved the use of the immunotherapy-based treatment pembrolizumab. While none of these options is perfect, the fact that we now have at least some alternatives is a huge step in the right direction.
5. It’s all about the patient: Involving patients in designing the health care delivery system
Although it seems like an obvious concept, patients themselves have traditionally not been involved in designing the health care delivery system on which they rely. Research presented at the AUA shows that many health care outcomes improve when patients are actively involved in the process. For example, Angela Smith, MD, of the University of North Carolina at Chapel Hill, presented a study showing that including patients in the identification of possible research topics helps them feel engaged and more likely to participate in studies. Patients who are involved in advisory councils at the local hospital level are more likely to report having received high-quality care. And surveying patients on the goals of national health care policy helps them feel that the outcomes are more equitable.
As a small-town urologist who spends his days in the trenches of urology, I think the next time my group considers participating in new cancer research, I may talk to the local cancer support group first. If Dr. Smith’s data are correct, not only would our patients be better served, but we would also have an easier time filling the trial!
The 2023 AUA conference is going to be held in Chicago next spring. I hope to see you there!
A version of this article first appeared on Medscape.com.
The annual meeting of the American Urological Association took place recently at the Ernest N. Morial Convention Center in New Orleans.
1. Updates to the AUA’s guidelines for management of localized kidney cancer
The AUA’s recommendations for the treatment of localized kidney cancer have changed dramatically over the past few decades. Gone are the days of simply removing the entire kidney every time a mass is found. Today, a partial nephrectomy is preferred in most situations.
Our understanding that the prevalence of familial kidney cancer is much higher than previously thought has led to a change in the guidelines regarding which patients should receive genetic counseling. For the first time, the guidelines include the use of adjuvant medical treatment, such as pembrolizumab. A 2021 study in the New England Journal of Medicine showed a survival benefit for patients with high-risk disease who receive such therapies, so it›s not surprising that such treatments are now recommended.
The development of new second- and third-generation gadolinium contrast agents that spare the kidneys has dramatically increased the role for MRIs for patients with severe or even end-stage renal disease. As a result, the guidelines were updated to recommend the use of these agents. The role of a renal biopsy, which has always been limited, given the ability of cross-sectional imaging to diagnosis this disease, has further been constrained and should now be performed only when the results would clearly change a clinical decision, such as whether or not the lesion in question is a metastasis.
2. New and better ureteroscope technology
No one likes kidney stones, not the patient who deals with the incredible pain, nor the surgeon who has to remove them, given that these cases often present in the wee hours of the morning. The preferred surgical approach has changed dramatically over the past decade, moving away from extracorporeal shockwave lithotripsy toward flexible ureteroscope-based technology, which has a higher clearance rate and is more widely and more immediately available. Flexible ureteroscopy has been held back by technological barriers, including limited scope deflection and low laser power. The exceptionally high cost of repair and the tendency of the instruments to break haven’t helped, either. Although single-use ureteroscopes have been available for some time, it wasn’t until the recently introduced second-generation scopes became widely available that they have become popular. These new scopes have small external diameters, great optics, and can easily be used. Newer high-powered lasers and the change from holmium:YAG-based lasers to thulium technology is greatly increasing the size of stones that can be safely addressed ureteroscopically. The cost analysis of single-use technology versus reusable scopes tends to be site dependent but can be appealing in certain situations. Also, on the technology forefront, a new robotically assisted ureteroscope is being introduced that offers the chance for improved intrapelvic mobility and better ergonomics for the surgeon.
3. New options for the treatment of clinically localized prostate cancer
Since the guidelines were last updated in 2017, the definitive management of localized prostate cancer has changed dramatically. Although radical prostatectomy and radiotherapy remain the preferred options for men who choose treatment for their disease, the updated guidelines state that active surveillance is now the preferred approach for men with low-risk cancers.
Although the preferred surveillance protocol is still being debated, the consensus is that almost all men with low-risk disease can be safely monitored for some period. The imaging technology available to monitor patients is also radically changing with the rollout of prostate-specific membrane antigen–based PET technology. The increased sensitivity and specificity of this modality opens the door not only for better up-front staging of newly diagnosed patients with prostate cancer but also may allow clinicians to earlier identify and treat men with metastatic disease. The guidelines for the first time address the use of genetic markers to individualize treatment of men with advanced or metastatic prostate cancer. Exactly which treatments these patients need is still being debated, but the ability to use patient-specific genetic mutation information to customize treatment is potentially groundbreaking.
4. New treatment options for patients with high-grade non–muscle-invasive bladder cancer (NMIBC) refractory to bacille Calmette-Guérin (BCG) therapy
Patients with NMIBC who do not respond to BCG therapy are in a tough position. Cystectomy remains the preferred option as a second-line strategy, but the procedure has a complication rate approaching 30%. Further, many patients are not willing to have their bladder removed because of the life-altering changes that go along with having an urostomy or a neobladder. While intravesical treatments such as valrubicin, docetaxel, or gemcitabine have been available for many years, the success rates of those options are limited. The Food and Drug Administration recently approved the use of the immunotherapy-based treatment pembrolizumab. While none of these options is perfect, the fact that we now have at least some alternatives is a huge step in the right direction.
5. It’s all about the patient: Involving patients in designing the health care delivery system
Although it seems like an obvious concept, patients themselves have traditionally not been involved in designing the health care delivery system on which they rely. Research presented at the AUA shows that many health care outcomes improve when patients are actively involved in the process. For example, Angela Smith, MD, of the University of North Carolina at Chapel Hill, presented a study showing that including patients in the identification of possible research topics helps them feel engaged and more likely to participate in studies. Patients who are involved in advisory councils at the local hospital level are more likely to report having received high-quality care. And surveying patients on the goals of national health care policy helps them feel that the outcomes are more equitable.
As a small-town urologist who spends his days in the trenches of urology, I think the next time my group considers participating in new cancer research, I may talk to the local cancer support group first. If Dr. Smith’s data are correct, not only would our patients be better served, but we would also have an easier time filling the trial!
The 2023 AUA conference is going to be held in Chicago next spring. I hope to see you there!
A version of this article first appeared on Medscape.com.
FROM AUA 2022
New guideline gives active surveillance a boost
Experts hailed the new guidelines, released May 10 by the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) as a boon for patients with low-risk to favorable intermediate-risk prostate cancers.
“The guideline is unequivocal that AS is the preferred management option for the majority of men with low-risk prostate cancer,” panel chair James A. Eastham, MD, Peter T. Scardino Chair in Oncology and chief of urology at Memorial Sloan Kettering Cancer Center, New York, said in an interview.
The new guideline is the first guideline for localized prostate cancer since 2017.
In the new document, guideline writers merged low-risk patients and very-low-risk patients into a single category of “low-risk.” Dr. Eastham said a distinction between very-low-risk and low-risk is inconsequential since the treatment for the two groups of patients is identical.
The 2022 guideline for the first time makes AS the recommended treatment for select patients with favorable intermediate-risk Gleason 3+4 prostate cancer, he said. The document also provides guidance on how such patients should be selected for AS.
Most research suggests that as many as 40% of patients newly diagnosed with prostate cancer have low-risk disease. Favorable intermediate-risk cancer represents 10%-15% of newly diagnosed patients, said Todd Morgan, MD, the Jack Lapides, MD, Research Professor and chief of urologic oncology at Michigan Medicine, Ann Arbor.
Dr. Morgan, who was not on the AUA/ASTRO panel, called the new recommendations “a very strong update compared to the guideline from 5 years ago.”
The guideline has been pared back some from 2017 to include fewer statements, but it covers several key clinical trials that have appeared over the past 6 years to strengthen the evidence base for the document, he said.
“I would say that we still have to acknowledge that many statements are based on ‘expert opinion’ rather than high-level evidence, which highlights the continued need for well-conducted studies that prove or disprove some of these statements,” Dr. Morgan added.
Patients weighed in
This year, AUA’s advocacy group urged patients to comment on the proposed guideline.
Rick Davis, founder of the AnCan Foundation, a virtual support network for prostate cancer and other diseases, thanked the groups for acknowledging the value of peer support and virtual support groups.
“AnCan congratulates the AUA/ASTRO on endorsing the proper role for the Active Surveillance protocol to manage early low-risk and favorable intermediate-risk prostate cancer and also their qualified and well-supported warnings against focal therapy,” Mr. Davis, who reviewed the guideline, said in an email. “We are, however, disappointed at the lack of a recommendation to provide comprehensive counseling when hormone therapy is prescribed.”
James Schraidt, another patient reviewer for AnCan, said that on balance, the 2022 guideline was an improvement over 2017 and will benefit patients.
He praised AUA/ASTRO for, at the urging of patient reviewers, introducing the “cribriform” and “intraductal” pathology patterns into the guideline for the first time as risk factors.
But he criticized the doctor groups for “a less than fulsome and orderly discussion of the use of MRI. It is not mentioned as a tool that should be used prior to initial biopsy, leaving the door wide open to random biopsies. The recommended role of MRI in AS monitoring was unclear.” He also said the panel should have reviewed micro-ultrasound, an emerging technology, that can be used by itself or to complement MRIs.
Many of the AUA/ASTRO guideline changes involve semantic issues – but which experts said nevertheless were important nuances.
Dr. Eastham said the AUA/ASTRO panel debated and finally settled on the word “preferred” for AS rather than “recommended” or “strongly recommended.”
“This is a very strong statement from the AUA/ASTRO,” Dr. Morgan said. “The semantics are definitely important, but ... ’preferred’ is actually a strong word. For the AUA, what’s really important is the ‘strong recommendation’ and Grade A level of evidence.”
Dr. Morgan also observed that the AS recommendations for patients with low-risk prostate cancer are stronger in the new AUA guideline than those in the latest recommendations from the National Comprehensive Cancer Network (NCCN), which he helped write.
The AUA/ASTRO guideline states that AS is preferred for patients with low-risk cancer, whereas in the NCCN guideline the language is: “preferred for most patients with low-risk disease cancer,” Dr. Morgan said.
“All of these statements ultimately acknowledge what I think that the vast majority of experts agree on – a small proportion of patients with low-risk prostate cancer may appropriately be recommended to undergo primary therapy,” he said.
Dr. Eastham said the goal of the guideline is to persuade surgeons to emphasize that AS is the best choice for most patients with low-risk prostate cancer: “The hope is that surgeons read the guideline. The guideline is definitive in recommending AS in low-risk prostate cancer.”
Dr. Eastham said the new guideline also does the following:
- Further endorses shared decisionmaking, with the understanding that for a decision to be made, both patient and physician need appropriate information regarding the risk posed by the cancer and the risk posed by treatment;
- Endorses selective use of somatic genetic testing when the data are needed for shared decisionmaking;
- Updates a section on genetic testing in patients considered to be at high risk for a germline mutation;
- Updates pretreatment evaluation for patients opting for treatment, primarily the role of imaging and how the evolution of next-generation imaging – such as , a new type of nuclear medicine procedure, in clinically localized prostate cancer;
- Addresses aspects of both radiotherapy and surgery, including nerve sparing, pelvic lymph node dissection, and adjuvant/neoadjuvant therapy, such as chemotherapy or hormone therapy delivered before or after the primary treatment. Dr. Eastham said the “significant evolution” in how best to provide radiotherapy resulted in several changes to this section.
No relevant financial relationships have been reported.
A version of this article first appeared on Medscape.com.
Experts hailed the new guidelines, released May 10 by the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) as a boon for patients with low-risk to favorable intermediate-risk prostate cancers.
“The guideline is unequivocal that AS is the preferred management option for the majority of men with low-risk prostate cancer,” panel chair James A. Eastham, MD, Peter T. Scardino Chair in Oncology and chief of urology at Memorial Sloan Kettering Cancer Center, New York, said in an interview.
The new guideline is the first guideline for localized prostate cancer since 2017.
In the new document, guideline writers merged low-risk patients and very-low-risk patients into a single category of “low-risk.” Dr. Eastham said a distinction between very-low-risk and low-risk is inconsequential since the treatment for the two groups of patients is identical.
The 2022 guideline for the first time makes AS the recommended treatment for select patients with favorable intermediate-risk Gleason 3+4 prostate cancer, he said. The document also provides guidance on how such patients should be selected for AS.
Most research suggests that as many as 40% of patients newly diagnosed with prostate cancer have low-risk disease. Favorable intermediate-risk cancer represents 10%-15% of newly diagnosed patients, said Todd Morgan, MD, the Jack Lapides, MD, Research Professor and chief of urologic oncology at Michigan Medicine, Ann Arbor.
Dr. Morgan, who was not on the AUA/ASTRO panel, called the new recommendations “a very strong update compared to the guideline from 5 years ago.”
The guideline has been pared back some from 2017 to include fewer statements, but it covers several key clinical trials that have appeared over the past 6 years to strengthen the evidence base for the document, he said.
“I would say that we still have to acknowledge that many statements are based on ‘expert opinion’ rather than high-level evidence, which highlights the continued need for well-conducted studies that prove or disprove some of these statements,” Dr. Morgan added.
Patients weighed in
This year, AUA’s advocacy group urged patients to comment on the proposed guideline.
Rick Davis, founder of the AnCan Foundation, a virtual support network for prostate cancer and other diseases, thanked the groups for acknowledging the value of peer support and virtual support groups.
“AnCan congratulates the AUA/ASTRO on endorsing the proper role for the Active Surveillance protocol to manage early low-risk and favorable intermediate-risk prostate cancer and also their qualified and well-supported warnings against focal therapy,” Mr. Davis, who reviewed the guideline, said in an email. “We are, however, disappointed at the lack of a recommendation to provide comprehensive counseling when hormone therapy is prescribed.”
James Schraidt, another patient reviewer for AnCan, said that on balance, the 2022 guideline was an improvement over 2017 and will benefit patients.
He praised AUA/ASTRO for, at the urging of patient reviewers, introducing the “cribriform” and “intraductal” pathology patterns into the guideline for the first time as risk factors.
But he criticized the doctor groups for “a less than fulsome and orderly discussion of the use of MRI. It is not mentioned as a tool that should be used prior to initial biopsy, leaving the door wide open to random biopsies. The recommended role of MRI in AS monitoring was unclear.” He also said the panel should have reviewed micro-ultrasound, an emerging technology, that can be used by itself or to complement MRIs.
Many of the AUA/ASTRO guideline changes involve semantic issues – but which experts said nevertheless were important nuances.
Dr. Eastham said the AUA/ASTRO panel debated and finally settled on the word “preferred” for AS rather than “recommended” or “strongly recommended.”
“This is a very strong statement from the AUA/ASTRO,” Dr. Morgan said. “The semantics are definitely important, but ... ’preferred’ is actually a strong word. For the AUA, what’s really important is the ‘strong recommendation’ and Grade A level of evidence.”
Dr. Morgan also observed that the AS recommendations for patients with low-risk prostate cancer are stronger in the new AUA guideline than those in the latest recommendations from the National Comprehensive Cancer Network (NCCN), which he helped write.
The AUA/ASTRO guideline states that AS is preferred for patients with low-risk cancer, whereas in the NCCN guideline the language is: “preferred for most patients with low-risk disease cancer,” Dr. Morgan said.
“All of these statements ultimately acknowledge what I think that the vast majority of experts agree on – a small proportion of patients with low-risk prostate cancer may appropriately be recommended to undergo primary therapy,” he said.
Dr. Eastham said the goal of the guideline is to persuade surgeons to emphasize that AS is the best choice for most patients with low-risk prostate cancer: “The hope is that surgeons read the guideline. The guideline is definitive in recommending AS in low-risk prostate cancer.”
Dr. Eastham said the new guideline also does the following:
- Further endorses shared decisionmaking, with the understanding that for a decision to be made, both patient and physician need appropriate information regarding the risk posed by the cancer and the risk posed by treatment;
- Endorses selective use of somatic genetic testing when the data are needed for shared decisionmaking;
- Updates a section on genetic testing in patients considered to be at high risk for a germline mutation;
- Updates pretreatment evaluation for patients opting for treatment, primarily the role of imaging and how the evolution of next-generation imaging – such as , a new type of nuclear medicine procedure, in clinically localized prostate cancer;
- Addresses aspects of both radiotherapy and surgery, including nerve sparing, pelvic lymph node dissection, and adjuvant/neoadjuvant therapy, such as chemotherapy or hormone therapy delivered before or after the primary treatment. Dr. Eastham said the “significant evolution” in how best to provide radiotherapy resulted in several changes to this section.
No relevant financial relationships have been reported.
A version of this article first appeared on Medscape.com.
Experts hailed the new guidelines, released May 10 by the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) as a boon for patients with low-risk to favorable intermediate-risk prostate cancers.
“The guideline is unequivocal that AS is the preferred management option for the majority of men with low-risk prostate cancer,” panel chair James A. Eastham, MD, Peter T. Scardino Chair in Oncology and chief of urology at Memorial Sloan Kettering Cancer Center, New York, said in an interview.
The new guideline is the first guideline for localized prostate cancer since 2017.
In the new document, guideline writers merged low-risk patients and very-low-risk patients into a single category of “low-risk.” Dr. Eastham said a distinction between very-low-risk and low-risk is inconsequential since the treatment for the two groups of patients is identical.
The 2022 guideline for the first time makes AS the recommended treatment for select patients with favorable intermediate-risk Gleason 3+4 prostate cancer, he said. The document also provides guidance on how such patients should be selected for AS.
Most research suggests that as many as 40% of patients newly diagnosed with prostate cancer have low-risk disease. Favorable intermediate-risk cancer represents 10%-15% of newly diagnosed patients, said Todd Morgan, MD, the Jack Lapides, MD, Research Professor and chief of urologic oncology at Michigan Medicine, Ann Arbor.
Dr. Morgan, who was not on the AUA/ASTRO panel, called the new recommendations “a very strong update compared to the guideline from 5 years ago.”
The guideline has been pared back some from 2017 to include fewer statements, but it covers several key clinical trials that have appeared over the past 6 years to strengthen the evidence base for the document, he said.
“I would say that we still have to acknowledge that many statements are based on ‘expert opinion’ rather than high-level evidence, which highlights the continued need for well-conducted studies that prove or disprove some of these statements,” Dr. Morgan added.
Patients weighed in
This year, AUA’s advocacy group urged patients to comment on the proposed guideline.
Rick Davis, founder of the AnCan Foundation, a virtual support network for prostate cancer and other diseases, thanked the groups for acknowledging the value of peer support and virtual support groups.
“AnCan congratulates the AUA/ASTRO on endorsing the proper role for the Active Surveillance protocol to manage early low-risk and favorable intermediate-risk prostate cancer and also their qualified and well-supported warnings against focal therapy,” Mr. Davis, who reviewed the guideline, said in an email. “We are, however, disappointed at the lack of a recommendation to provide comprehensive counseling when hormone therapy is prescribed.”
James Schraidt, another patient reviewer for AnCan, said that on balance, the 2022 guideline was an improvement over 2017 and will benefit patients.
He praised AUA/ASTRO for, at the urging of patient reviewers, introducing the “cribriform” and “intraductal” pathology patterns into the guideline for the first time as risk factors.
But he criticized the doctor groups for “a less than fulsome and orderly discussion of the use of MRI. It is not mentioned as a tool that should be used prior to initial biopsy, leaving the door wide open to random biopsies. The recommended role of MRI in AS monitoring was unclear.” He also said the panel should have reviewed micro-ultrasound, an emerging technology, that can be used by itself or to complement MRIs.
Many of the AUA/ASTRO guideline changes involve semantic issues – but which experts said nevertheless were important nuances.
Dr. Eastham said the AUA/ASTRO panel debated and finally settled on the word “preferred” for AS rather than “recommended” or “strongly recommended.”
“This is a very strong statement from the AUA/ASTRO,” Dr. Morgan said. “The semantics are definitely important, but ... ’preferred’ is actually a strong word. For the AUA, what’s really important is the ‘strong recommendation’ and Grade A level of evidence.”
Dr. Morgan also observed that the AS recommendations for patients with low-risk prostate cancer are stronger in the new AUA guideline than those in the latest recommendations from the National Comprehensive Cancer Network (NCCN), which he helped write.
The AUA/ASTRO guideline states that AS is preferred for patients with low-risk cancer, whereas in the NCCN guideline the language is: “preferred for most patients with low-risk disease cancer,” Dr. Morgan said.
“All of these statements ultimately acknowledge what I think that the vast majority of experts agree on – a small proportion of patients with low-risk prostate cancer may appropriately be recommended to undergo primary therapy,” he said.
Dr. Eastham said the goal of the guideline is to persuade surgeons to emphasize that AS is the best choice for most patients with low-risk prostate cancer: “The hope is that surgeons read the guideline. The guideline is definitive in recommending AS in low-risk prostate cancer.”
Dr. Eastham said the new guideline also does the following:
- Further endorses shared decisionmaking, with the understanding that for a decision to be made, both patient and physician need appropriate information regarding the risk posed by the cancer and the risk posed by treatment;
- Endorses selective use of somatic genetic testing when the data are needed for shared decisionmaking;
- Updates a section on genetic testing in patients considered to be at high risk for a germline mutation;
- Updates pretreatment evaluation for patients opting for treatment, primarily the role of imaging and how the evolution of next-generation imaging – such as , a new type of nuclear medicine procedure, in clinically localized prostate cancer;
- Addresses aspects of both radiotherapy and surgery, including nerve sparing, pelvic lymph node dissection, and adjuvant/neoadjuvant therapy, such as chemotherapy or hormone therapy delivered before or after the primary treatment. Dr. Eastham said the “significant evolution” in how best to provide radiotherapy resulted in several changes to this section.
No relevant financial relationships have been reported.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF UROLOGY
Most men with low-risk prostate tumors now forgoing treatment
, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.
Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.
Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.
Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.
In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.
Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.
Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”
In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.
Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.
“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”
The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.
In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.
In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
Aiming higher
William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”
Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.
However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.
Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”
Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.
“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”
Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”
Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.
Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.
Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.
Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.
In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.
Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.
Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”
In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.
Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.
“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”
The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.
In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.
In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
Aiming higher
William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”
Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.
However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.
Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”
Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.
“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”
Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”
Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.
Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.
Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.
Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.
In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.
Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.
Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”
In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.
Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.
“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”
The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.
In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.
In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
Aiming higher
William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”
Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.
However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.
Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”
Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.
“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”
Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”
Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AUA ANNUAL MEETING
Value of screening urinalysis before office procedures questioned
according to the results of a randomized trial.
Some centers perform the pre-procedure test to avoid urinary tract infections (UTIs), a feared iatrogenic complication, but the new findings indicate the step is unnecessary.
These results “will alter screening urinalysis practice at our hospital,” said Alexa Rose, a clinical research coordinator in the department of urology, University of Wisconsin School of Medicine and Public Health, Madison. Ms. Rose’s group presented the findings at the annual meeting of the American Urological Association.
Although rates of post procedure UTI are generally low after office-based cytology, it is the most common complication, Ms. Rose said. To minimize risk, preprocedural urinalysis had become standard practice at her institution.
For the study, Ms. Rose and colleagues sought to determine if the testing was indeed helping reduce the risk of UTI. They randomly divided 641 patients into two groups. Both received urinalysis, but test results of participants in the experimental group were not forwarded to clinicians.
Patients were undergoing one of three types of office urology procedures: cystoscopy (66.6%), intravesical therapy for bladder cancer (24.5%), and prostate biopsy (8.9%). Median age was 70 years and most participants (83%) were men.
The primary endpoint was a symptomatic UTI confirmed by culture 30 days after the procedure.
In the 323 patients managed without access to the results of urinalysis, the rate of UTI was 1.2%. In the 318 patients who received usual care guided by urinalysis, the rate of UTI was 1.6% – and the difference was a single case.
The nonsignificant difference fell easily within the study definition of noninferiority, according to Ms. Rose. Others offering preprocedural urinalysis should take heed.
“Due to the large cohort of patients we enrolled, we expect that it will be applicable to other institutions,” she said in an interview.
SUB: Expert pushes back
In a 2020 Best Practice Statement from the AUA on antibiotic prophylaxis, the risk of procedural-related UTI was considered to be much lower in out-patient versus in-patient settings.
The statement identified a long list of variables to guide screening for UTI and initiation of prophylactic antibiotics prior to urology procedures for hospitalized patients, but office-based procedures in low-risk, largely healthy patients were treated differently.
As a result, the operating hypothesis of the Wisconsin study is “flawed,” said Anthony J. Schaeffer, MD, professor of urology, Feinberg School of Medicine at Northwestern University, Chicago.
“An asymptomatic patient undergoing office cystoscopy for [such indications as] hematuria or bladder tumor doesn’t need pre-procedural urinalysis or prophylactic antibiotics unless they have risk factors, such as immunosuppression,” Dr. Schaeffer told this news organization. “There is no relationship between preprocedural urinalysis and a post-procedure UTI caused by instrumentation.”
According to the AUA, neither antibiotic prophylaxis nor screening such as urodynamic studies is recommended prior to simple outpatient cystoscopy if patients are otherwise healthy and have no signs or symptoms of a UTI.
While antibiotic prophylaxis is standard of care for some outpatient urological procedures, such as transrectal ultrasound (TRUS)-guided prostate biopsies, the practice is appropriate whether or not patients undergo urinalysis, according to Dr. Schaeffer.
As a result, one problem with the new study was the lack of discussion about antibiotic prophylaxis.
“Presumably the patients undergoing TRUS prostate biopsies received antibiotic prophylaxis, which is a critical cofounder that they do not even mention,” Dr. Schaeffer said.
In patients with UTI symptoms, some screening is appropriate whether with a simple dipstick, laboratory-performed microscopy, or culture, according to the AUA.
In the absence of symptoms for a patient undergoing a class I (clean) procedure, the AUA statement recommends – and Dr. Schaeffer said he agreed – that antibiotic prophylaxis, let alone urinalysis, is not a standard, particularly for simple outpatient cystoscopy.
Ms. Rose and Dr. Schaeffer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to the results of a randomized trial.
Some centers perform the pre-procedure test to avoid urinary tract infections (UTIs), a feared iatrogenic complication, but the new findings indicate the step is unnecessary.
These results “will alter screening urinalysis practice at our hospital,” said Alexa Rose, a clinical research coordinator in the department of urology, University of Wisconsin School of Medicine and Public Health, Madison. Ms. Rose’s group presented the findings at the annual meeting of the American Urological Association.
Although rates of post procedure UTI are generally low after office-based cytology, it is the most common complication, Ms. Rose said. To minimize risk, preprocedural urinalysis had become standard practice at her institution.
For the study, Ms. Rose and colleagues sought to determine if the testing was indeed helping reduce the risk of UTI. They randomly divided 641 patients into two groups. Both received urinalysis, but test results of participants in the experimental group were not forwarded to clinicians.
Patients were undergoing one of three types of office urology procedures: cystoscopy (66.6%), intravesical therapy for bladder cancer (24.5%), and prostate biopsy (8.9%). Median age was 70 years and most participants (83%) were men.
The primary endpoint was a symptomatic UTI confirmed by culture 30 days after the procedure.
In the 323 patients managed without access to the results of urinalysis, the rate of UTI was 1.2%. In the 318 patients who received usual care guided by urinalysis, the rate of UTI was 1.6% – and the difference was a single case.
The nonsignificant difference fell easily within the study definition of noninferiority, according to Ms. Rose. Others offering preprocedural urinalysis should take heed.
“Due to the large cohort of patients we enrolled, we expect that it will be applicable to other institutions,” she said in an interview.
SUB: Expert pushes back
In a 2020 Best Practice Statement from the AUA on antibiotic prophylaxis, the risk of procedural-related UTI was considered to be much lower in out-patient versus in-patient settings.
The statement identified a long list of variables to guide screening for UTI and initiation of prophylactic antibiotics prior to urology procedures for hospitalized patients, but office-based procedures in low-risk, largely healthy patients were treated differently.
As a result, the operating hypothesis of the Wisconsin study is “flawed,” said Anthony J. Schaeffer, MD, professor of urology, Feinberg School of Medicine at Northwestern University, Chicago.
“An asymptomatic patient undergoing office cystoscopy for [such indications as] hematuria or bladder tumor doesn’t need pre-procedural urinalysis or prophylactic antibiotics unless they have risk factors, such as immunosuppression,” Dr. Schaeffer told this news organization. “There is no relationship between preprocedural urinalysis and a post-procedure UTI caused by instrumentation.”
According to the AUA, neither antibiotic prophylaxis nor screening such as urodynamic studies is recommended prior to simple outpatient cystoscopy if patients are otherwise healthy and have no signs or symptoms of a UTI.
While antibiotic prophylaxis is standard of care for some outpatient urological procedures, such as transrectal ultrasound (TRUS)-guided prostate biopsies, the practice is appropriate whether or not patients undergo urinalysis, according to Dr. Schaeffer.
As a result, one problem with the new study was the lack of discussion about antibiotic prophylaxis.
“Presumably the patients undergoing TRUS prostate biopsies received antibiotic prophylaxis, which is a critical cofounder that they do not even mention,” Dr. Schaeffer said.
In patients with UTI symptoms, some screening is appropriate whether with a simple dipstick, laboratory-performed microscopy, or culture, according to the AUA.
In the absence of symptoms for a patient undergoing a class I (clean) procedure, the AUA statement recommends – and Dr. Schaeffer said he agreed – that antibiotic prophylaxis, let alone urinalysis, is not a standard, particularly for simple outpatient cystoscopy.
Ms. Rose and Dr. Schaeffer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to the results of a randomized trial.
Some centers perform the pre-procedure test to avoid urinary tract infections (UTIs), a feared iatrogenic complication, but the new findings indicate the step is unnecessary.
These results “will alter screening urinalysis practice at our hospital,” said Alexa Rose, a clinical research coordinator in the department of urology, University of Wisconsin School of Medicine and Public Health, Madison. Ms. Rose’s group presented the findings at the annual meeting of the American Urological Association.
Although rates of post procedure UTI are generally low after office-based cytology, it is the most common complication, Ms. Rose said. To minimize risk, preprocedural urinalysis had become standard practice at her institution.
For the study, Ms. Rose and colleagues sought to determine if the testing was indeed helping reduce the risk of UTI. They randomly divided 641 patients into two groups. Both received urinalysis, but test results of participants in the experimental group were not forwarded to clinicians.
Patients were undergoing one of three types of office urology procedures: cystoscopy (66.6%), intravesical therapy for bladder cancer (24.5%), and prostate biopsy (8.9%). Median age was 70 years and most participants (83%) were men.
The primary endpoint was a symptomatic UTI confirmed by culture 30 days after the procedure.
In the 323 patients managed without access to the results of urinalysis, the rate of UTI was 1.2%. In the 318 patients who received usual care guided by urinalysis, the rate of UTI was 1.6% – and the difference was a single case.
The nonsignificant difference fell easily within the study definition of noninferiority, according to Ms. Rose. Others offering preprocedural urinalysis should take heed.
“Due to the large cohort of patients we enrolled, we expect that it will be applicable to other institutions,” she said in an interview.
SUB: Expert pushes back
In a 2020 Best Practice Statement from the AUA on antibiotic prophylaxis, the risk of procedural-related UTI was considered to be much lower in out-patient versus in-patient settings.
The statement identified a long list of variables to guide screening for UTI and initiation of prophylactic antibiotics prior to urology procedures for hospitalized patients, but office-based procedures in low-risk, largely healthy patients were treated differently.
As a result, the operating hypothesis of the Wisconsin study is “flawed,” said Anthony J. Schaeffer, MD, professor of urology, Feinberg School of Medicine at Northwestern University, Chicago.
“An asymptomatic patient undergoing office cystoscopy for [such indications as] hematuria or bladder tumor doesn’t need pre-procedural urinalysis or prophylactic antibiotics unless they have risk factors, such as immunosuppression,” Dr. Schaeffer told this news organization. “There is no relationship between preprocedural urinalysis and a post-procedure UTI caused by instrumentation.”
According to the AUA, neither antibiotic prophylaxis nor screening such as urodynamic studies is recommended prior to simple outpatient cystoscopy if patients are otherwise healthy and have no signs or symptoms of a UTI.
While antibiotic prophylaxis is standard of care for some outpatient urological procedures, such as transrectal ultrasound (TRUS)-guided prostate biopsies, the practice is appropriate whether or not patients undergo urinalysis, according to Dr. Schaeffer.
As a result, one problem with the new study was the lack of discussion about antibiotic prophylaxis.
“Presumably the patients undergoing TRUS prostate biopsies received antibiotic prophylaxis, which is a critical cofounder that they do not even mention,” Dr. Schaeffer said.
In patients with UTI symptoms, some screening is appropriate whether with a simple dipstick, laboratory-performed microscopy, or culture, according to the AUA.
In the absence of symptoms for a patient undergoing a class I (clean) procedure, the AUA statement recommends – and Dr. Schaeffer said he agreed – that antibiotic prophylaxis, let alone urinalysis, is not a standard, particularly for simple outpatient cystoscopy.
Ms. Rose and Dr. Schaeffer have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AUA ANNUAL MEETING